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Urinary StoneNCT06628765

Two Types of Single-use Flexible Ureteroscopies for the Treatment of Upper Urinary Tract Stones in Children

A study testing 8.6 Fr single-use fURS (XFGC-FU-660RC) and 6.3 Fr single-use fURS (Hugemed, HU30S) in people with Urinary Stone, run by The Children's Hospital of Zhejiang University School of Medicine at 1 site in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

The single-use digital flexible Ureteroscopy (fURS) is commonly used for the treatment of upper urinary tract stones. The size of the outer diameter of the fURS can affect the safety, efficacy, and medical costs of the treatment. Read more about this study

Who is it for?
Ages 0 to 14 years
Conditions the study is for
Urinary Stone
What is being tested?
8.6 Fr single-use fURS (XFGC-FU-660RC) and 6.3 Fr single-use fURS (Hugemed, HU30S)
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
52 participants
Where
1 siteChina
Study dates
8 Oct 2024to 8 Apr 2025
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 0 to 14 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • Patients scheduled for ureteroscopy and laser lithotripsy for individual renal stones ranging in size from 5 mm to 20 mm in all intrarenal locations (If there are multiple stones present, the total stone burden in cross section should not exceed 20 mm)
  • Patients < 14 years
  • For children younger than 8 years old, the informed consent form is signed by the parents; for children older than 8 years old, the informed consent form is signed by both the parents and the child themselves.

Who cannot join

  • Children with uncontrolled urinary tract infections or coagulation disorders and other contraindications for surgery before the operation.
  • Children with severe renal insufficiency, anatomical or functional solitary kidney, known nephrocalcinosis, and other significant comorbidities that are not suitable for participating in the study.
  • Children who refuse to participate in this study.
  • Any other reason that in the opinion of the investigator would make the participant unsuitable for enrollment in the study.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Aimei Ma contact

+86 15888864134

maaimei@zju.edu.cn

China1 site, 1 recruiting

  • Children's hospital, Zhejiang University School of Medicine

    Hangzhou, Zhejiang, 310052

    Hongbo Liu, +86 19329110160, 19329110160@zju.edu.cn

    Recruiting

Other trials in China

About this study

Official title: Two Types of Single-use Flexible Ureteroscopies for the Treatment of Upper Urinary Tract Stones in Children: A Single-center Randomized Controlled Trial

The single-use digital flexible Ureteroscopy (fURS) is commonly used for the treatment of upper urinary tract stones. The size of the outer diameter of the fURS can affect the safety, efficacy, and medical costs of the treatment. Particularly for children, their ureters are thinner and more tortuous compared to adults, which places higher demands on medical devices. The investigators are interested in determining if the performance of the two different sizes of fURS (6.3 Fr vs. 8.6 Fr) are equivalent. This study will have guiding significance for the selection of upper urinary tract stones surgery in children in the future.

Read the detailed description

The single-use digital fURS is a sterile, disposable, flexible endoscope. Compared to traditional reusable digital flexible endoscopes, single-use digital fURS has lower maintenance costs, is easier to operate, and effectively avoids cross-infection between patients. With technological advancements, the size of single-use digital fURS has become increasingly slim, making them particularly suitable for children with narrow and tortuous ureters who suffered urinary stones. Currently, the single-use digital fURS used in our unit has an outer diameter of 8.6Fr. For younger children, the success rate of the first insertion of the fURS is still relatively low. When the fURS cannot pass through the ureter, it is necessary to actively dilate the ureter with a balloon in one stage, or passively dilate it with a urethral stent during the procedure to facilitate a second-stage fURS procedure. This not only increases the risk of ureteral injury but also incurs additional medical expenses. Recently, HugeMed Company has launched a single-use digital fURS with an outer diameter of 6.3 Fr, which is currently the thinnest single-use fURS in the world, and its effectiveness and safety have been preliminarily verified in clinical practice. The purpose of this study is to compare the safety and efficacy of the 6.3 Fr fURS (HU30S) and the 8.6 Fr fURS (XFGC-FU-660RC) in the clinical treatment of upper urinary tract stones in children.

Conditions
Urinary Stone
Being tested
8.6 Fr single-use fURS (XFGC-FU-660RC), 6.3 Fr single-use fURS (Hugemed, HU30S)
Keywords
Urinary Stone, Flexible Ureteroscopy, Children
Medical subject headings
Urinary Calculi

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 8.6 Fr single-use fURS (XFGC-FU-660RC)Device

    Comparative device

  • 6.3 Fr single-use fURS (Hugemed, HU30S)Device

    Device being tested

Study groups in NCT06628765
Study groupRoleWhat they receive
8.6 Fr single-use fURS (XFGC-FU-660RC)Active comparator8.6 Fr single-use fURS (XFGC-FU-660RC) arm received 8.6 Fr single-use fURS
Receives: Device: 8.6 Fr single-use fURS (XFGC-FU-660RC)
6.3 Fr single-use fURS (HugeMed, HU30S)Experimental6.3 Fr single-use fURS (HugeMed, HU30S) arm received 6.3 Fr single-use fURS
Receives: Device: 6.3 Fr single-use fURS (Hugemed, HU30S)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. The success rate of the first fURS insertion

    The first insertion of fURS is successful without the need for balloon dilation or passive dilation with a stent.

    Measured: During the procedure

Secondary outcomes (9)

  1. Ureteral access sheath placement (Yes/No)

    Whether a ureteral access sheath is placed during the procedure

    Measured: During the procedure

  2. Balloon dilation rate

    Due to difficulty in passing the fURS through the ureter, balloon dilation of the ureter is performed during the procedure

    Measured: During the procedure

  3. Pre-placement rate of double-J stents

    Due to difficulty in passing the fURS through the ureter, the double-J stent is placed during the surgery to passively dilate the ureter, facilitating a second-stage fURS procedure

    Measured: During the procedure

  4. Surgical duration

    From the initiation of fURS insertion to the completion of lithotripsy, the fURS is withdrawn from the body

    Measured: During the procedure

  5. Blood loss

    Intraoperative blood loss

    Measured: During the procedure

  6. Indwelling catheter duration

    Indwelling catheter duration postoperatively

    Measured: Three days postoperatively

  7. Postoperative hospital stay

    Postoperative hospital stay

    Measured: Up to one week postoperatively

  8. Perioperative complications

    Pain (e.g. dysuria and lumbar pain), Hematuria, Frequency and urgency of urination, Fever

    Measured: Through study completion, up to two months postoperatively

  9. Stone-free rate at 4 weeks postoperatively

    Stone-free status was evaluated at 4-week and defined as a single residual fragment ≤2 mm

    Measured: 4 weeks postoperatively

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Oct 2024
  2. Study start8 Oct 2024
  3. Primary completion8 Apr 2025 (estimated)
  4. Study completion8 Apr 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
52 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06628765
Sponsor's protocol ID
2024-IRB-0310-P-01
Status last verified
Nov 2024
First submitted
28 Sep 2024
Last updated
12 Nov 2024
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Hu Q, Liu H, Lin C, Ru W, Xu Z, Hu L, Xu Z, He K, Liu L, Yan X. Efficacy and safety of 6.3-Fr versus 8.6-Fr disposable digital flexible ureteroscopes for pediatric upper urinary tract stones </= 2 cm: a randomized controlled trial. World J Urol. 2026 Mar 24;44(1):259. doi: 10.1007/s00345-026-06352-x.

    PubMed 41876909

Questions about this trial

What is this clinical trial studying?

A study testing 8.6 Fr single-use fURS (XFGC-FU-660RC) and 6.3 Fr single-use fURS (Hugemed, HU30S) in people with Urinary Stone, run by The Children's Hospital of Zhejiang University School of Medicine at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 12 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Aimei Ma (+86 15888864134, maaimei@zju.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The success rate of the first fURS insertion (time frame: During the procedure). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06628765, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Nov 2024.

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